AzTrials
AzTrials

Relapsing Multiple SclerosisPhase 3NCT06372145

A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.

A Phase 3 study testing Tolebrutinib and Teriflunomide in people with Relapsing Multiple Sclerosis and Secondary Progressive Multiple Sclerosis, run by Sanofi at 352 sites in 47 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a Phase 3 extension, global, multicenter study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 tolebrutinib pivotal trials (GEMINI 1 [EFC16033]… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tolebrutinib and Teriflunomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,500 participants
Where
352 sitesin 47 countries
Study dates
16 Apr 2024to 30 Apr 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with RMS, PPMS, or NRSPMS who completed the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 pivotal tolebrutinib trials (EFC16033, EFC16034, EFC16645, EFC16035) on IMP.
  • OR
  • The Phase 2b LTS (LTS16004) or Phase 3 tolebrutinib pivotal trial participants who temporarily discontinued IMP due to a national emergency and completed the trial visits.
  • ToleDYNAMIC Substudy: Inclusion criteria are those of the main study

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply:
  • The participant is at risk for or has a persistent chronic, active (including fever higher than 38°C and clinically unstable), or recurring systemic infection, as judged by the Investigator
  • For participants initiating OL tolebrutinib in the LTS17043 study: Participants at risk of developing or having reactivation of hepatitis, ie, results at the unblinding visit (RMS) or opt-in visit (PMS) for serological markers for hepatitis B and C viruses indicating acute or chronic infection
  • Active alcohol use disorder or a history of alcohol or drug abuse within 1 year prior to the opt-in visit
  • Current alcohol intake equal to or exceeding the following at the opt-in visit: more than 2 drinks per day for men and more than 1 drink per day for women
  • Abnormal ECG during the opt-in visit considered in the Investigator's judgment to be clinically significant, such as QTcF >500 msec, in the context of this study.
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  • A bleeding disorder, known platelet dysfunction, abnormal platelet count (<100,000/microliter), history of significant bleeding event or other conditions and planned procedures that may predispose the participant to excessive bleeding during the study, as judged by the Investigator.
  • For participants initiating OL tolebrutinib in the LTS17043 study: Confirmed unblinding visit (RMS) or opt-in visit (PMS) alanine aminotransferase (ALT) more than 1.5 × upper limit of normal (ULN) OR aspartate aminotransferase (AST) more than 1.5 × ULN OR alkaline phosphatase more than 2 × ULN (unless caused by non-liver-related disorder or explained by a stable chronic liver disorder) OR total bilirubin more than 1.5 × ULN (unless due to Gilbert syndrome or non-liver-related disorder).
  • Acute liver disease, cirrhosis, chronic liver disease (unless considered stable for more than 6 months).
  • Participants who developed clinically relevant cardiovascular, hepatic, endocrine, neuropsychiatric or other major systemic disease making implementation of the protocol or interpretation of the trial results difficult or that would put the patient at risk by participating in the trial, as judged by the Investigator.
  • The participant is receiving treatment during the study period with drugs not permitted by the study protocol, including potent and moderate inducers of cytochrome P450 (CYP) 3A or potent inhibitors of CYP2C8 hepatic enzymes.
  • NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
  • ToleDYNAMIC Substudy: Exclusion criteria are those of the main study

Trial locations and contacts

352 sites in 47 countries.

352 sites in 47 countries

United States52 sites

  • University of New Mexico- Site Number : 8400032

    Albuquerque, New Mexico, 87131

  • The NeuroMedical Center- Site Number : 8400057

    Baton Rouge, Louisiana, 70810

  • The University of Alabama at Birmingham- Site Number : 8400013

    Birmingham, Alabama, 35233

  • SFM Clinical Research, LLC- Site Number : 8400029

    Boca Raton, Florida, 33487

  • Tufts Medical Center- Site Number : 8400072

    Boston, Massachusetts, 02111

  • University of Vermont - Larner College of Medicine- Site Number : 8400130

    Burlington, Vermont, 05405

  • Dayton Center for Neurological Disorders- Site Number : 8400081

    Centerville, Ohio, 45459

  • Cleveland Clinic Foundation-Mellen Center for MS- Site Number : 8400125

    Cleveland, Ohio, 44195

  • The Ohio State University Wexner Medical Center- Site Number : 8400150

    Columbus, Ohio, 43221

  • The Boster Center for Multiple Sclerosis- Site Number : 8400147

    Columbus, Ohio, 43235

  • ~North Central Neurology Associates, PC- Site Number : 8400009

    Cullman, Alabama, 35058

  • UC Health, LLC- Site Number : 8409901

    Dayton, Ohio, 45417

  • University of Colorado- Site Number : 8400012

    Denver, Colorado, 80262

  • Wayne State University- Site Number : 8400046

    Detroit, Michigan, 48201

  • Michigan Institute Neuro Disorders- Site Number : 8400058

    Farmington Hills, Michigan, 48334

  • Advanced Neurosciences Research- Site Number : 8400025

    Fort Collins, Colorado, 80528

  • Indiana University Health, Inc- Site Number : 8400039

    Fort Wayne, Indiana, 46815

  • University of Florida Health- Site Number : 8400159

    Gainesville, Florida, 32608

  • Minneapolis Clinic of Neurology- Site Number : 8400051

    Golden Valley, Minnesota, 55422

  • Premier Neurology- Site Number : 8400069

    Greenville, South Carolina, 29605

  • University of Kansas Medical Center- Site Number : 8400023

    Kansas City, Kansas, 66160-7321

  • HOPE Neurology- Site Number : 8409904

    Knoxville, Tennessee, 37922

  • Lou Ruvo Center for Brain Health- Site Number : 8400117

    Las Vegas, Nevada, 89106

  • University of Kentucky- Site Number : 8400106

    Lexington, Kentucky, 40536

  • Collaborative Neuroscience Research- Site Number : 8400045

    Los Alamitos, California, 90720

  • USC- Site Number : 8400143

    Los Angeles, California, 90033

  • Norton Neurology MS Services- Site Number : 8400127

    Louisville, Kentucky, 40207

  • Neurology Associates- Site Number : 8409902

    Maitland, Florida, 32751

  • University of Miami- Site Number : 8400063

    Miami, Florida, 33136

  • Aqualane Clinical Research- Site Number : 8400027

    Naples, Florida, 34105

  • Ochsner Clinic Foundation- Site Number : 8400107

    New Orleans, Louisiana, 70121

  • Mount Sinai Medical Center- Site Number : 8400038

    New York, New York, 10021

  • Consultants In Neurology- Site Number : 8409906

    Northbrook, Illinois, 60062

  • Memorial Healthcare Institute for Neuroscience- Site Number : 8400033

    Owosso, Michigan, 48867

  • Sharlin Health & Neurology- Site Number : 8400093

    Ozark, Missouri, 65721

  • NYU Langone South Shore Neurologic Associates- Site Number : 8400100

    Patchogue, New York, 11772

  • Center for Neurology and Spine- Site Number : 8400089

    Phoenix, Arizona, 85018

  • Providence Multiple Sclerosis Center- Site Number : 8400020

    Portland, Oregon, 97225

  • Neurological Associates- Site Number : 8400097

    Richmond, Virginia, 23229

  • Mayo Clinic- Site Number : 8400111

    Rochester, Minnesota, 55905

  • Lone Star Neurology of San Antonio- Site Number : 8400036

    San Antonio, Texas, 78258

  • University of California San Diego Medical Center- Site Number : 8400101

    San Diego, California, 92037-0943

  • Velocity Clinical Research- Site Number : 8409903

    Savannah, Georgia, 31406

  • Springfield Clinic, LLP- Site Number : 8400071

    Springfield, Illinois, 62702

  • Missouri Baptist Medical Center- Site Number : 8400019

    St Louis, Missouri, 63131

  • Neurology Associates of Stony Brook- Site Number : 8400042

    Stony Brook, New York, 11794

  • Axiom Clinical Research of Florida- Site Number : 8400001

    Tampa, Florida, 33609-4052

  • University of South Florida- Site Number : 8409905

    Tampa, Florida, 33612

  • Georgetown University Medical Center- Site Number : 8400119

    Washington D.C., District of Columbia, 20007

  • Regina Berkovich, MD, PhD- Site Number : 8400059

    West Hollywood, California, 90048

  • Wake Forest University Baptist Medical Center- Site Number : 8400116

    Winston-Salem, North Carolina, 27157

  • University of Massachusetts- Site Number : 8400014

    Worcester, Massachusetts, 01655

Other trials in United States

China21 sites

  • Investigational Site Number : 1560006

    Beijing, 100034

  • Investigational Site Number : 1560023

    Beijing, 100191

  • Investigational Site Number : 1560009

    Beijing, 100730

  • Investigational Site Number : 1560025

    Beijing, 100730

  • Investigational Site Number : 1560004

    Changchun, 130021

  • Investigational Site Number : 1560015

    Changsha, 410008

  • Investigational Site Number : 1560005

    Chengdu, 610041

  • Investigational Site Number : 1560019

    Chongqing, 400016

  • Investigational Site Number : 1560035

    Fuzhou, 350005

  • Investigational Site Number : 1569903

    Guangzhou, 510630

  • Investigational Site Number : 1560027

    Hohhot, 010020

  • Investigational Site Number : 1560044

    Nanjing, 210008

  • Investigational Site Number : 1560042

    Nanjing, 210029

  • Investigational Site Number : 1569901

    Shanghai, 200040

  • Investigational Site Number : 1560018

    Shenyang, 110004

  • Investigational Site Number : 1560014

    Shijiazhuang, 050000

  • Investigational Site Number : 1560008

    Taiyuan, 030001

  • Investigational Site Number : 1560020

    Tianjin, 300052

  • Investigational Site Number : 1560026

    Wenzhou, 325000

  • Investigational Site Number : 1560011

    Wuhan, 430030

  • Investigational Site Number : 1560017

    Xi'an, 710038

Other trials in China

Spain21 sites

  • Investigational Site Number : 7249908

    A Coruña, A Coruña [La Coruña], 15006

  • Investigational Site Number : 7249913

    Barakaldo, Bizkaia, 48903

  • Investigational Site Number : 7249906

    Barcelona, Barcelona [Barcelona], 08035

  • Investigational Site Number : 7249912

    Barcelona, Barcelona [Barcelona], 08036

  • Investigational Site Number : 7249914

    Córdoba, 14004

  • Investigational Site Number : 7249918

    Donostia / San Sebastian, Gipuzkoa, 20014

  • Investigational Site Number : 7249919

    L'Hospitalet de Llobregat, Barcelona [Barcelona], 08907

  • Investigational Site Number : 7249904

    Las Palmas de Gran Canaria, Las Palmas, 35010

  • Investigational Site Number : 7249902

    Lleida / Lleida, Lleida [Lérida], 25198

  • Investigational Site Number : 7249903

    Madrid, 28034

  • Investigational Site Number : 7249910

    Madrid, 28040

  • Investigational Site Number : 7249909

    Madrid / Madrid, Madrid, Comunidad de, 28007

  • Investigational Site Number : 7249901

    Majadahonda, Madrid, 28222

  • Investigational Site Number : 7249915

    Málaga, 29010

  • Investigational Site Number : 7249916

    Murcia, 30120

  • Investigational Site Number : 7249920

    Palma de Mallorca, 07120

  • Investigational Site Number : 7249905

    Pozuelo de Alarcón, Madrid, 28223

  • Investigational Site Number : 7249911

    Salt, Girona [Gerona], 17190

  • Investigational Site Number : 7249921

    Santiago de Compostela, Galicia [Galicia], 15706

  • Investigational Site Number : 7249907

    Seville, Andalusia, 41009

  • Investigational Site Number : 7249917

    Valencia, 46026

Other trials in Spain

Ukraine17 sites

  • Investigational Site Number : 8040020

    Chernivtsi, 14029

  • Investigational Site Number : 8049912

    Chernivtsi, 58000

  • Investigational Site Number : 8049904

    Chernivtsi, 58023

  • Investigational Site Number : 8049905

    Dnipro, 49089

  • Investigational Site Number : 8049908

    Ivano-Frankivsk, 76493

  • Investigational Site Number : 8040025

    Kharkiv, 61058

  • Investigational Site Number : 8049903

    Kharkiv, 61068

  • Investigational Site Number : 8040018

    Kharkiv, 61166

  • Investigational Site Number : 8049902

    Kyiv, 01135

  • Investigational Site Number : 8049911

    Kyiv, 02091

  • Investigational Site Number : 8049901

    Kyiv, 03115

  • Investigational Site Number : 8049914

    Lutsk, 43005

  • Investigational Site Number : 8049909

    Lviv, 79010

  • Investigational Site Number : 8049906

    Lviv, 79029

  • Investigational Site Number : 8049913

    Odesa, 65025

  • Investigational Site Number : 8049910

    Vinnytsia, 21001

  • Investigational Site Number : 8040024

    Vinnytsia, 21009

Other trials in Ukraine

France16 sites

  • Investigational Site Number : 2500019

    Besançon, 25030

  • Investigational Site Number : 2500011

    Bron, 69500

  • Investigational Site Number : 2500005

    Clermont-Ferrand, 63000

  • Investigational Site Number : 2500015

    Gonesse, 95500

  • Investigational Site Number : 2500009

    Lille, 59037

  • Investigational Site Number : 2500006

    Montpellier, 34295

  • Investigational Site Number : 2500008

    Nancy, 54035

  • Investigational Site Number : 2500010

    Nantes, 44093

  • Investigational Site Number : 2500002

    Nice, 06001

  • Investigational Site Number : 2500017

    Nîmes, 30029

  • Investigational Site Number : 2500014

    Paris, 75013

  • Investigational Site Number : 2500007

    Paris, 75019

  • Investigational Site Number : 2500004

    Poissy, 78300

  • Investigational Site Number : 2500003

    Rennes, 35033

  • Investigational Site Number : 2500001

    Strasbourg, 67091

  • Investigational Site Number : 2500012

    Toulouse, 31059

Other trials in France

Italy16 sites

  • Investigational Site Number : 3800011

    Bergamo, 24127

  • Investigational Site Number : 3800007

    Cagliari, 09126

  • Investigational Site Number : 3800015

    Catania, 95123

  • Investigational Site Number : 3800018

    Chieti, 66100

  • Investigational Site Number : 3800012

    Florence, Tuscany, 50134

  • Investigational Site Number : 3800016

    Florence, 50134

  • Investigational Site Number : 3800014

    Genova, 16132

  • Investigational Site Number : 3800010

    Milan, Lombardy, 20133

  • Investigational Site Number : 3800001

    Milan, Milano, 20132

  • Investigational Site Number : 3800006

    Naples, 80138

  • Investigational Site Number : 3800008

    Pavia, 27100

  • Investigational Site Number : 3800002

    Pozzilli, Isernia, 86077

  • Investigational Site Number : 3800005

    Roma, 00152

  • Investigational Site Number : 3800009

    Roma, 00168

  • Investigational Site Number : 3800013

    Roma, 00189

  • Investigational Site Number : 3800009

    Rome, Roma, 00168

Other trials in Italy

Canada14 sites

  • Investigational Site Number : 1240017

    Burnaby, British Columbia, V5G 2X6

  • Investigational Site Number : 1240002

    Edmonton, Alberta, T6G 2C8

  • Investigational Site Number : 1240006

    Gatineau, Quebec, J8Y 1W2

  • Investigational Site Number : 1240011

    Halifax, Nova Scotia, B3H4K4

  • Investigational Site Number : 1240012

    Hamilton, Ontario, L8L 2X2

  • Investigational Site Number : 1240021

    Lévis, Quebec, G6W0M5

  • Investigational Site Number : 1240004

    Montreal, Quebec, H2X 0A9

  • Investigational Site Number : 1240015

    Montreal, Quebec, H3A 2B4

  • Investigational Site Number : 1240003

    Ottawa, Ontario, K1H 8L6

  • Investigational Site Number : 1240001

    Québec, G1J 1Z4

  • Investigational Site Number : 1240007

    Sherbrooke, Quebec, J1H 5N4

  • Investigational Site Number : 1240008

    Toronto, Ontario, M4N 3M5

  • Investigational Site Number : 1240013

    Toronto, Ontario, M5B 1W8

  • Investigational Site Number : 1249901

    Vancouver, British Columbia, V6T 2B5

Other trials in Canada

Germany14 sites

  • Investigational Site Number : 2760005

    Bayreuth, 95445

  • Investigational Site Number : 2760009

    Berlin, 10117

  • Investigational Site Number : 2760015

    Berlin, 10713

  • Investigational Site Number : 2760014

    Berlin, 12099

  • Investigational Site Number : 2760020

    Bochum, 44791

  • Investigational Site Number : 2760001

    Dresden, 01307

  • Investigational Site Number : 2769901

    Düsseldorf, 40225

  • Investigational Site Number : 2760012

    Essen, 45147

  • Investigational Site Number : 2760002

    Giessen, 35392

  • Investigational Site Number : 2760016

    Hamburg, 22179

  • Investigational Site Number : 2760018

    München, 81377

  • Investigational Site Number : 2760008

    Münster, 48149

  • Investigational Site Number : 2760011

    Ulm, 89081

  • Investigational Site Number : 2760003

    Würzburg, 97074

Other trials in Germany

Turkey (Türkiye)13 sites

  • Investigational Site Number : 7920006

    Ankara, 06100

  • Investigational Site Number : 7920005

    Eskişehir, 26040

  • Investigational Site Number : 7920003

    Istanbul, 34096

  • Investigational Site Number : 7920002

    Istanbul, 34303

  • Investigational Site Number : 7920009

    Istanbul, 34668

  • Investigational Site Number : 7920007

    Istanbul, 34785

  • Investigational Site Number : 7920014

    Izmir, 35340

  • Investigational Site Number : 7920010

    Izmir, 35360

  • Investigational Site Number : 7920001

    Kocaeli, 41380

  • Investigational Site Number : 7920017

    Konya, 42080

  • Investigational Site Number : 7929901

    Kütahya, 43100

  • Investigational Site Number : 7929902

    Mersin, 33070

  • Investigational Site Number : 7929903

    Samsun, 55200

Other trials in Turkey (Türkiye)

Czechia11 sites

  • Investigational Site Number : 2039907

    Brno, 62500

  • Investigational Site Number : 2030002

    Brno, 65691

  • Investigational Site Number : 2039903

    Hradec Králové, 50005

  • Investigational Site Number : 2039901

    Jihlava, 58633

  • Investigational Site Number : 2039902

    Ostrava - Poruba, 70852

  • Investigational Site Number : 2039904

    Pardubice, 53203

  • Investigational Site Number : 2030008

    Prague, 10034

  • Investigational Site Number : 2039906

    Prague, 12808

  • Investigational Site Number : 2039905

    Praha 5 - Motol, 15000

  • Investigational Site Number : 2030003

    Teplice, 41501

  • Investigational Site Number : 2030007

    Zlín, 76275

Other trials in Czechia

Japan11 sites

  • Investigational Site Number : 3920014

    Bunkyo-ku, Tokyo, 113-8431

  • Investigational Site Number : 3920016

    Chiba, Chiba, 260-8677

  • Investigational Site Number : 3920018

    Kawagoe-shi, Saitama, 350-8550

  • Investigational Site Number : 3920011

    Kyoto, Kyoto, 616-8255

  • Investigational Site Number : 3920004

    Moriguchi-shi, Osaka, 570-8507

  • Investigational Site Number : 3920022

    Morioka, Iwate, 020-8505

  • Investigational Site Number : 3920001

    Osaka, Osaka, 556-0016

  • Investigational Site Number : 3920010

    Ōta-ku, Tokyo, 146-0065

  • Investigational Site Number : 3920023

    Sagamihara-shi, Kanagawa, 252-0392

  • Investigational Site Number : 3920020

    Sendai, Miyagi, 980-8574

  • Investigational Site Number : 3920015

    Toyama, Toyama, 930-0194

Other trials in Japan

United Kingdom11 sites

  • Investigational Site Number : 8260009

    Bristol, BS161LE

  • Investigational Site Number : 8260001

    Cardiff, Vale of Glamorgan, the, CF4 4XN

  • Investigational Site Number : 8260003

    Exeter, Devon, EX2 5DW

  • Investigational Site Number : 8260016

    Kent, Kent, CT1 3NG

  • Investigational Site Number : 8260006

    London, London, City of, EC1M 6BQ

  • Investigational Site Number : 8260005

    London, London, City of, SW17 0RE

  • Investigational Site Number : 8260014

    Newcastle upon Tyne, NE1 4LP

  • Investigational Site Number : 8260012

    Nottingham, Nottinghamshire, NG7 2UH

  • Investigational Site Number : 8260013

    Oxford, Oxfordshire, OX3 9DU

  • Investigational Site Number : 8260019

    Salford, M6 8HD

  • Investigational Site Number : 8260010

    Swansea, Neath Port Talbot, SA6 6NL

Other trials in United Kingdom

Poland10 sites

  • Investigational Site Number : 6160003

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

  • Investigational Site Number : 6160009

    Glogow Mlp., Podkarpackie Voivodeship, 36-060

  • Investigational Site Number : 6160004

    Katowice, Silesian Voivodeship, 40-686

  • Investigational Site Number : 6160002

    Katowice, Silesian Voivodeship, 40571

  • Investigational Site Number : 6160001

    Lodz, Lódzkie, 90-549

  • Investigational Site Number : 6160012

    Lublin, Lublin Voivodeship, 20-410

  • Investigational Site Number : 6160008

    Plewiska, Greater Poland Voivodeship, 62-064

  • Investigational Site Number : 6160005

    Warsaw, Masovian Voivodeship, 01-211

  • Investigational Site Number : 6160006

    Warsaw, Masovian Voivodeship, 01-684

  • Investigational Site Number : 6160011

    Zabrze, Silesian Voivodeship, 41-800

Other trials in Poland

India9 sites

  • Investigational Site Number : 3560014

    Bengaluru, 560001

  • Investigational Site Number : 3569904

    Chandigarh, 160015

  • Investigational Site Number : 3560002

    Delhi, 110060

  • Investigational Site Number : 3560007

    Gūrgaon, 122001

  • Investigational Site Number : 3569903

    Gūrgaon, 122002

  • Investigational Site Number : 3569901

    Mangaluru, 575018

  • Investigational Site Number : 3560009

    Nagpur, 440012

  • Investigational Site Number : 3569902

    New Delhi, 110029

  • Investigational Site Number : 3560004

    Thiruvananthapuram, 695011

Other trials in India

Argentina8 sites

  • Investigational Site Number : 0320002

    CABA, Buenos Aires, C1012AAR

  • Investigational Site Number : 0320004

    CABA, Buenos Aires, C1023AAB

  • Investigational Site Number : 0320007

    CABA, Buenos Aires F.D., C1021

  • Investigational Site Number : 0320001

    CABA, Buenos Aires F.D., C1424

  • Investigational Site Number : 0329901

    CABA, Buenos Aires F.D., C1425 BKU

  • Investigational Site Number : 0320006

    Córdoba, 5000

  • Investigational Site Number : 0320003

    Rosario, Santa Fe Province, 2000

  • Investigational Site Number : 0320005

    San Miguel de Tucumán, 4000

Other trials in Argentina

Bulgaria8 sites

  • Investigational Site Number : 1000002

    Pleven, 5809

  • Investigational Site Number : 1000005

    Plovdiv, 4002

  • Investigational Site Number : 1000004

    Sofia, 1113

  • Investigational Site Number : 1000008

    Sofia, 1407

  • Investigational Site Number : 1000001

    Sofia, 1431

  • Investigational Site Number : 1000006

    Sofia, 1431

  • Investigational Site Number : 1000011

    Sofia, 1606

  • Investigational Site Number : 1000009

    Sofia, 1680

Other trials in Bulgaria

Portugal8 sites

  • Investigational Site Number : 6200001

    Braga, 4710-243

  • Investigational Site Number : 6200005

    Coimbra, 3000-075

  • Investigational Site Number : 6200011

    Lisbon, 1169-050

  • Investigational Site Number : 6200007

    Lisbon, 1349-019

  • Investigational Site Number : 6200012

    Lisbon, 1500-650

  • Investigational Site Number : 6200006

    Lisbon, 1649-035

  • Investigational Site Number : 6200002

    Matosinhos Municipality, 4464-513

  • Investigational Site Number : 6200004

    Santa Maria da Feira, 4520-211

Other trials in Portugal

Romania8 sites

  • Investigational Site Number : 6420015

    Brasov, 500283

  • Investigational Site Number : 6420008

    Bucharest, 022328

  • Investigational Site Number : 6420004

    Campulung Muscel, 115100

  • Investigational Site Number : 6420006

    Cluj-Napoca, 400012

  • Investigational Site Number : 6420003

    Constanța, 900123

  • Investigational Site Number : 6420013

    Oradea, 410154

  • Investigational Site Number : 6420005

    Sibiu, 550052

  • Investigational Site Number : 6420002

    Timișoara, 300723

Other trials in Romania

Belgium7 sites

  • Investigational Site Number : 0560005

    Bruges, 8000

  • Investigational Site Number : 0560009

    Brussels, 1070

  • Investigational Site Number : 0560004

    Ghent, 9000

  • Investigational Site Number : 0560006

    Leuven, 3000

  • Investigational Site Number : 0560008

    Liège, 4000

  • Investigational Site Number : 0560001

    Overpelt, 3900

  • Investigational Site Number : 0560007

    Woluwe-Saint-Lambert, 1200

Other trials in Belgium

Greece7 sites

  • Investigational Site Number : 3000001

    Athens, 115 28

  • Investigational Site Number : 3000006

    Athens, 11525

  • Investigational Site Number : 3000002

    Athens, 12462

  • Investigational Site Number : 3000004

    Larissa, 41110

  • Investigational Site Number : 3000007

    Marousi, 15125

  • Investigational Site Number : 3000003

    Thessaloniki, 54636

  • Investigational Site Number : 3000009

    Thessaloniki, 55236

Other trials in Greece

Serbia5 sites

  • Investigational Site Number : 6880001

    Belgrade, 11000

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Brazil4 sites

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    Goiânia, Goiás, 74605-020

  • Hospital Sao Lucas da PUCRS- Site Number : 0760001

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Chile4 sites

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Hungary4 sites

  • Investigational Site Number : 3489901

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Israel4 sites

  • Investigational Site Number : 3760003

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  • Investigational Site Number : 3760001

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Mexico4 sites

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Netherlands4 sites

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Austria3 sites

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Sweden2 sites

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Taiwan2 sites

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Colombia1 site

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About this study

Official title: An Interventional, Phase 3 Extension Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Relapsing Multiple Sclerosis, Primary Progressive Multiple Sclerosis, or Nonrelapsing Secondary Progressive Multiple Sclerosis

This is a Phase 3 extension, global, multicenter study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b LTS (LTS16004) or 1 of the 4 Phase 3 tolebrutinib pivotal trials (GEMINI 1 [EFC16033], GEMINI 2 [EFC16034], HERCULES [EFC16645], or PERSEUS [EFC16035]).

SUBSTUDY: ToleDYNAMIC substudy

Read the detailed description

Participants with relapsing MS from the Phase 2b LTS16004 parent study will continue open-label (OL) tolebrutinib.

All participants from the Phase 3 parent studies (EFC16033, EFC16034, EFC16645, and EFC16035) will learn which treatment they received in the parent study:

  • If from one of the Phase 3 relapsing MS studies and on teriflunomide, an accelerated elimination procedure or a 3-month washout period is required prior to starting OL tolebrutinib. If on teriflunomide, and benefiting and recommended by the Investigator, the participant may opt to continue teriflunomide outside of the LTS17043 study, if clinically appropriate. If on tolebrutinib, the participant will continue tolebrutinib.
  • All participants from one of the Phase 3 progressive MS studies will start OL tolebrutinib.
  • If a participant already started OL tolebrutinib in the Phase 3 parent study this will be continued.
  • RMS participants who are not eligible for OL tolebrutinib per Health Authority and/or ethics committee decisions on the study conduct (ie, partial hold on initiation of tolebrutinib) will continue their parent study treatment assignment as per their randomization from the parent study.

The treatment duration per participant will be approximately 4 years of OL tolebrutinib.

Being tested
Tolebrutinib, Placebo, Teriflunomide
Medical subject headings
Multiple Sclerosis, Chronic Progressive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TolebrutinibDrug

    Also called SAR442168

    Pharmaceutical form:Tablet-Route of administration:oral

  • PlaceboDrug

    Pharmaceutical form:Tablet-Route of administration:oral

  • TeriflunomideDrug

    Also called Aubagio

    Pharmaceutical form:Tablet-Route of administration:oral

Study groups in NCT06372145
Study groupRoleWhat they receive
TolebrutinibExperimental* Participants will receive OL tolebrunitib 60 mg once daily. * RMS participants who are not eligible for OL tolebrutinib per Health Authority and/or ethics committee decisions on the study conduct (ie, partial hold on initiation of tolebrutinib) will continue their parent study treatment assignment as per their randomization from the parent study.
Receives: Drug: Tolebrutinib; Drug: Placebo
TeriflunomideActive comparator* participants will receive teriflunomide 14 mg daily * RMS participants who are not eligible for OL tolebrutinib per Health Authority and/or ethics committee decisions on the study conduct (ie, partial hold on initiation of tolebrutinib) will continue their parent study treatment assignment (either tolebrutinib or teriflunomide) as per their randomization from the parent study. If unblinded to teriflunomide parent study treatment assignment, these RMS participants will continue teriflunomide in the LTS17043 study.
Receives: Drug: Placebo; Drug: Teriflunomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and AEs leading to permanent study intervention discontinuation

    Measured: From baseline until the End of study approximately 4 years per participant

  2. Number of Participants with Potentially clinically significant abnormalities (PCSAs)

    Potentially clinically significant abnormalities (PCSAs) determined by laboratory tests, electrocardiogram (ECG), or vital signs and safety findings on MRI during the study period.

    Measured: From baseline until the End of study approximately 4 years per participant

Secondary outcomes (5)

  1. Time to onset of 6-month confirmed disability worsening (CDW for RMS) or confirmed disability progression (CDP for PPMS and NRSPMS) for participants from pivotal studies

    Time to onset is defined as a sustained increase from baseline EDSS (pivotal trial) of:

    • RMS: ≥1.5 points when the baseline score is 0, ≥1.0 point when the baseline score is 0.5 to ≤5.5 or ≥0.5 point when the baseline score is >5.5
    • PPMS: ≥1.0 point when the baseline score is ≤5.5 or ≥0.5 point when the baseline score is >5.5
    • NRSPMS: ≥1.0 point when the baseline score is ≤5.0 or ≥0.5 point when the baseline score is >5.0

    Measured: From baseline until the End of study approximately 4 years per participant

  2. Annualized Relapse Rate (ARR) for RMS only

    ARR during the OL treatment period assessed by confirmed protocol-defined relapses

    Measured: From baseline until the End of study approximately 4 years per participant

  3. Number of new and/or enlarging T2-hyperintense lesions per year

    Measured: From baseline until the End of study approximately 4 years per participant

  4. Change from baseline in total volume of T2-hyperintense lesions

    Measured: From baseline until the End of study approximately 4 years per participant

  5. ToleDYNAMIC substudy Change from baseline in biomarkers

    Measured: From baseline until 12 months per participant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2024
  2. Study start16 Apr 2024
  3. Primary completion30 Apr 2029 (estimated)
  4. Study completion30 Apr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
2,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06372145
Sponsor's protocol ID
LTS17043
Other IDs
2023-503631-18, U1111-1287-6797, 2023
Status last verified
Aug 2026
First submitted
15 Apr 2024
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • Maxwell CR, Turner TJ, Wallstroem E, Patel S, Pappas SC, Lewis JH, Andrade RJ, Syed S. Tolebrutinib liver safety: A detailed overview. Mult Scler Relat Disord. 2026 Jul 23;113:107404. doi: 10.1016/j.msard.2026.107404. Online ahead of print.

    PubMed 42546561

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tolebrutinib and Teriflunomide in people with Relapsing Multiple Sclerosis and Secondary Progressive Multiple Sclerosis, run by Sanofi at 352 sites in 47 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 352 sites in United States, China, Spain, Ukraine, France and 42 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) and AEs leading to permanent study intervention discontinuation (time frame: From baseline until the End of study approximately 4 years per participant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06372145, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.

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